Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT00419133
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult male and non-pregnant female adults aged 18-40 years and healthy children aged 1-17 years
All subjects must satisfy the following criteria at study entry:
* Male or female adult residents aged 18-40 years or children aged 1- 17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection)
* For females of reproductive age, they must not be pregnant (as determined by verbal screening)
* Written informed consent obtained from subjects or their guardians, and written assent for children aged 12-17 years.
* Healthy subjects as determined by: medical history, physical examination, clinical judgement of the investigator.
Exclusion Criteria:
* Ongoing serious chronic disease
* Immunocompromising condition or therapy
* Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
* one or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
* one or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
* intake of any anti-diarrhoeal medicine in the past week
* abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
* acute disease one week prior to enrollment, with or without fever. Temperature \> or = 38 degrees C (oral) or axillary temperature \> or = 37.5 degrees C warrants deferral of the vaccination pending recovery of the subject
* receipt of antibiotics in past 14 days
* receipt of live or killed enteric vaccine in last month
* receipt of killed oral cholear vaccine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
40 Years
Study:
NCT00419133
Study Brief:
Protocol Section:
NCT00419133